[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-gastric-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-gastric-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100618588","phase-1-a-hypoxia-inducible-car-t-cell-targeting-axl-and-cd73-for-advanced-gastric-cancer-100618588",false,"NCT07333573","A Hypoxia-Inducible CAR-T Cell Targeting AXL and CD73 for Advanced Gastric Cancer","A Single-arm, Open-label Phase I\u002FII Study to Evaluate the Safety and Preliminary Efficacy of Hypoxia-Inducible CD73\u002FAXL-Targeting CAR-T Cells (XW-LTH-03) in Patients With Advanced Gastric Cancer","Inclusion Criteria:\n\n1. Aged 18 to 75 years, male or female.\n2. Clinically judged as unresectable Stage IV gastric cancer that has progressed on or is intolerant to standard therapy, or patients who voluntarily forego standard therapy.\n3. Patients must provide tumor tissue samples, with positive AXL and CD73 confirmed by immunohistochemical (IHC) staining at a central laboratory: AXL positivity rate ≥50% with staining intensity ≥++, and CD73 positivity rate ≥30% with staining intensity ≥+.\n4. ECOG Performance Status score of ≤ 1.\n5. Life expectancy of ≥ 3 months.\n6. At least one measurable lesion (≥ 1 cm).\n7. More than 4 weeks since the last failed treatment, and any toxicities from previous treatments must have recovered to Grade ≤ 1.\n8. Adequate organ function and bone marrow reserve, as defined by the following laboratory values within a specified period before enrollment:\n\n1\\. Hemoglobin (Hb) ≥ 90 g\u002FL. 2. Absolute Neutrophil Count (ANC) ≥ 1.0 × 10\\^9\u002FL. 3. Absolute Lymphocyte Count ≥ 0.5 × 10\\^9\u002FL. 4. Platelet count ≥ 100 × 10\\^9\u002FL. 5. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN).\n\n6\\. Serum amylase and lipase ≤ 1.0 × ULN. 7. Total bilirubin ≤ 1.5 × ULN. 8. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n\n9\\. Prothrombin Time (PT) or International Normalized Ratio (INR), and Partial Thromboplastin Time (PTT) \\\u003C 1.5 × ULN. (Patients receiving warfarin or heparin anticoagulation therapy may be enrolled if no underlying abnormality in these parameters is suspected, but require close monitoring with at least weekly testing until INR is stable).\n\n9\\. Adequate cardiac and pulmonary function. 10. Women of childbearing potential must have a negative pregnancy test within 7 days before treatment initiation. All subjects must agree to use effective contraception during the treatment period and for 1 year thereafter.\n\n11\\. Voluntary signing of a written informed consent form, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Active, known, or highly suspected autoimmune disease.\n2. Patients with brain metastases who have active central nervous system symptoms. (Note: Patients with brain metastases who completed radiotherapy at least 3 months prior to enrollment and remain asymptomatic from CNS disease may be eligible).\n3. Active, uncontrolled systemic infection.\n4. Receiving high-dose corticosteroids (\\>10 mg\u002Fday of methylprednisolone or equivalent doses of other corticosteroids) or other immunosuppressive therapy within 14 days prior to enrollment.\n5. History of severe allergy to other monoclonal antibodies.\n6. Intolerance or allergy to the investigational drug.\n7. History of interstitial lung disease.\n8. Evidence of organ failure:\n\n   * Cardiac: Class III or IV heart failure (per NYHA or other applicable criteria).\n   * Hepatic: Class C liver function as per Child-Pugh score.\n   * Renal: Renal failure or uremia stage.\n   * Pulmonary: Symptoms of severe respiratory failure.\n   * Neurological: Impaired consciousness.\n9. Active Hepatitis B (HBsAg positive with detectable HBV DNA), active Hepatitis C (HCV RNA positive), or HIV antibody positive.\n10. History of organ transplantation.\n11. Active gastrointestinal bleeding, or history of gastrointestinal bleeding within the past month.\n12. History of drug abuse, or psychological\u002Fpsychiatric disorders that may compromise compliance with the study.\n13. Any unstable condition or situation that may jeopardize the patient's safety or compliance in the study.\n14. Thyroid dysfunction.\n15. Prior treatment with any form of adoptive T-cell therapy.\n16. Currently receiving anticoagulant or antiplatelet therapy.\n17. Major surgery or significant trauma within 4 weeks prior to enrollment.\n18. History of other malignant tumors within the past 3 years.\n19. Judged by the investigator as unsuitable for cell therapy.","ALL","18 Years","75 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a single-arm, open-label clinical study evaluating the safety and preliminary efficacy of a novel hypoxia-inducible, bispecific CD73\u002FAXL-targeting CAR-T cell product, XW-LTH-03, in patients with stage IV gastric cancer (GC). The primary objective is to assess the safety and tolerability of XW-LTH-03 infusions. Secondary objectives include the evaluation of its antitumor efficacy and the characterization of its pharmacokinetic profile by measuring the in vivo expansion and persistence of the CAR-T cells. Exploratory analyses aim to identify potential biomarkers associated with clinical response and toxicity, as well as to investigate the cellular and molecular mechanisms underlying potential treatment resistance.",[28],"Stage IV Gastric Cancer","NOT_YET_RECRUITING","2025-12-30",{"date":32,"type":33},"2026-01-12","ACTUAL",{"date":35,"type":21},"2026-01-01",{"date":37,"type":21},"2027-06-30",{"name":39,"class":40},"Shanghai Zhongshan Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":5},"100379539","radiation-therapy-for-the-treatment-of-metastatic-gastrointestinal-cancers-100379539","NCT04221893","Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers","Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)","Inclusion Criteria:\n\n1. Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).\n2. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.\n3. Patients must have at least two metastases which are individually progressing as per RECIST criteria, one of which can be safely unirradiated as adjudicated by the treating radiation oncologist (e.g. lesions for which small increases in dimensions are unlikely to precipitate significant symptoms).\n4. Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example:\n\n   * Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea\n   * At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise\n5. Evaluation by a radiation oncologist within 28 days of study registration.\n6. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.\n7. Age \\>= 18 years.\n8. Life expectancy exceeding 6 months.\n9. Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \\>= 50.\n10. Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after completion of radiation therapy. Contraception requirements during the follow-up period of 6 months will be according to standard of care for immunotherapy administration.\n\n    a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.\n2. Administration of radiation therapy within 4 weeks prior to study enrollment.\n3. Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.\n4. Radiation therapy is contraindicated as adjudicated by the radiation oncologist.",{"count":50,"type":21},28,[52],"NA","This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.",[55,56,28,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"Stage IV Esophageal Adenocarcinoma","Stage IV Esophageal Squamous Cell Carcinoma","Stage IV Adenocarcinoma of the Gastroesophageal Junction","Stage IVA Esophageal Adenocarcinoma","Stage IVA Esophageal Squamous Cell Carcinoma","Stage IVA Gastric Cancer","Stage IVA Adenocarcinoma of the Gastroesophageal Junction","Stage IVB Esophageal Adenocarcinoma","Stage IVB Esophageal Squamous Cell Carcinoma","Stage IVB Gastric Cancer","Stage IVB Gastroesophageal Junction Adenocarcinoma","Metastatic Anal Canal Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Digestive System Neoplasm","Metastatic Small Intestinal Carcinoma","Pancreatobiliary Carcinoma","Pathologic Stage IV Gastric Cancer AJCC v8","Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Stage IV Anal Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVC Colorectal Cancer AJCC v8","RECRUITING","2025-09-30",{"date":101,"type":33},"2025-10-06",{"date":103,"type":33},"2020-08-07",{"date":105,"type":21},"2028-04-30",{"name":107,"class":40},"University of California, San Francisco"]